More Americans died in 2007 of hepatitis C infection, which causes incurable liver disease, than from the virus that causes AIDS, US health authorities said this week.
Hiển thị các bài đăng có nhãn obesity. Hiển thị tất cả bài đăng
Hiển thị các bài đăng có nhãn obesity. Hiển thị tất cả bài đăng
Thứ Sáu, 24 tháng 2, 2012
Thứ Năm, 23 tháng 2, 2012
FDA panel backs previously rejected obesity pill
SILVER SPRING, Md. (AP) — A previously rejected weight loss pill won an overwhelming endorsement from public health advisers Wednesday, raising hopes that the drug from Vivus Inc. could become the first new anti-obesity medication to reach the U.S. market in more than a decade.
The Food and Drug Administration has rejected three weight loss pills in the last two years, including Vivus' pill Qnexa, due to safety concerns. Experts agree new weight loss drugs are needed to treat an estimated 75 million obese adults in the U.S., but the string of rejections has raised questions of whether any pharmaceutical treatment is safe enough to win approval.
At a public meeting Wednesday, an FDA panel of outside physicians voted 20-2 in favor of the weight loss drug from Vivus, setting the stage for a potential comeback for a drug that has been plagued by safety questions since it was first submitted to the agency in 2010.
Nearly all the panelists backed the drug due to its impressive weight loss results, with most patients losing nearly 10 percent of their overall weight after a year on the drug. But the group stressed that the drugmaker must be required to conduct a large, follow-up study of the pill's effects on the heart. Studies of Qnexa show it raises heart rate and causes heart palpitations, a longtime concern with diet pills over the years. The group of experts said it is still unclear if those side effects lead to heart attack and more serious cardiovascular problems.
"The potential benefits of this medication seem to trump the side effects, but in truth, only time will tell," said Dr. Kenneth Burman of the Washington Hospital Center.
The FDA is not required to follow the advice of its panels, though it often does. A final decision on the drug is expected by mid-April.
In a key question, the physicians said Vivus could conduct the cardiovascular safety study after FDA approval. A requirement to conduct the study ahead of market approval would cost the company millions of dollars and take at least three more years.
"There is an urgent need for better pharmacologic options for individual patients with obesity," said Dr. Elaine Morrato, of the University of Colorado. "I believe Qnexa demonstrated a meaningful efficacy benefit and that there are consequences to not treating obesity."
Vivus, based in Mountain View, Calif., is one of three small drugmakers racing to bring the first new prescription weight loss drug to market in more than a decade. In the past two years the Food and Drug Administration has rejected pills from all three: Arena Pharmaceuticals Inc., Orexigen Therapeutics Inc. and Vivus. All three companies are in the process of resubmitting their products.
The FDA rejected Qnexa in October 2010, citing numerous side effects including elevated heart rate, psychiatric problems and birth defects. Vivus has resubmitted the drug with additional follow-up information on safety, hoping for a more favorable ruling.
Vivus President Peter Tam said the overwhelming panel vote Wednesday indicates doctors recognize the urgent need for effective weight loss drugs.
"Right now there aren't any good treatments out there besides dieting and bariatric surgery — clearly there's a huge gap," Tam said.
With U.S. obesity rates nearing 35 percent among adults, doctors and public health officials say new weight-loss therapies are desperately needed. And even a modestly effective drug could have blockbuster potential. Analysts expect a new weight loss pill to garner at least 10 million users within a few years.
Qnexa is a combination of two older drugs: the amphetamine phentermine, which is approved for short-term weight loss, and topiramate, an anti-seizure and anti-migraine drug sold by Johnson & Johnson as Topamax. Phentermine helps suppress appetite, while topiramate is supposed to make patients feel more satiated.
Along with heart safety, panelists raised concerns about potential birth defects in women who become pregnant while taking Qnexa: topiramate is known to more than double the risk of birth defects.
There were 34 pregnancies among 3,386 women enrolled in Vivus' studies of Qnexa, despite precautions to make sure women used contraception. An FDA expert on birth defects estimated there would be five babies born with a cleft lip defect for every 1,000 women who became pregnant while taking Qnexa.
If approved, FDA scientists said they would require Vivus to train prescribers to educate patients on the pregnancy risks of Qnexa. The drug would only be available from 10 mail-order pharmacies.
Qnexa's other ingredient, phentermine, was one half of the dangerous fen-phen combination, a weight loss treatment pushed by doctors that was never approved by the FDA. The regimen was linked to heart-valve damage and lung problems in the late 1990s, and the FDA forced drugmaker Wyeth to withdraw two versions of its drug fenfluramine.
Fen-phen is just one example in the decadeslong history of failed weight loss drugs, which have continued to pile up in recent years.
Four years ago Sanofi-Aventis SA discontinued studies of its highly anticipated pill Acomplia due to psychiatric side effects, including depression and suicidal thoughts. In 2010, Abbott Laboratories withdrew its drug Meridia after a study showed it increased heart attack and stroke. The drug won approval in 1997 in the wake of the recall of fenfluramine but never achieved widespread use due to modest weight loss and safety concerns. Only 100,000 prescriptions were written in the U.S. during Meridia's last full-year on the market.
Currently there is just one prescription drug on the market for long-term weight loss: Roche's Xenical, which is sold over the counter as alli by GlaxoSmithKline. The drug is not widely used because of modest weight loss results and unpleasant side effects, including gas and diarrhea.
U.S. advisers back experimental obesity pill
SILVER SPRING, Maryland (Reuters) - An experimental obesity drug from Vivus Inc won the backing of a U.S. advisory panel on Wednesday, raising hopes regulators would approve a weight-loss pill for the first time in 13 years.
A panel of outside experts to the Food and Drug Administration voted 20-2 to recommend approval of Qnexa, meant to treat obesity and its accompanying health problems.
The FDA rejected Vivus' Qnexa in 2010 because of safety concerns related to heart rate and birth defects, along with two other obesity pills that are also seeking a second round of consideration.
An advisory committee in 2010 voted 10-6 that safety concerns overwhelmed the benefits of Qnexa.
But this time most panelists were convinced that Qnexa's benefits to treat obesity outweighed its risks, but adding that there should be a post-approval study on heart risks.
Panelist also supported the company's plans to carefully control who gets the drug and limit it to women who are not pregnant. These plans were not part of Vivus's first submission.
"I think everyone around the room knows obesity and its substantial health risks," said Dr. Susan Yanovski, panel member and director of the obesity and eating disorders program at the National Institutes of Health.
"I would say not treating obesity is not risk neutral. We have few treatments for obesity for those who don't respond to lifestyle treatments."
The FDA usually follows panel recommendations, although it is not required to. It will make a final decision by April 17.
Qnexa, which combines the appetite suppressant phentermine and anti-seizure drug topiramate, helped patients lose at least 10 percent of their weight after a year of treatment, the company said.
Obesity, a leading cause of diabetes, heart disease and other serious health problems, has reached epidemic proportions in the United States, with about a third of the population obese and more than half overweight.
The FDA has set a high approval bar for weight loss drugs because such a large portion of the general population is likely to want to take them, and has not approved a new obesity drug since 1999.
Shares of Vivus were halted on Nasdaq on Wednesday pending the outcome of the FDA panel meeting. They closed at $10.55 on Tuesday, well above the stock's low around $4.70 after the pill was first rejected.
(Reporting by Anna Yukhananov; Editing by Tim Dobbyn)
U.S. advisers back experimental obesity pill
SILVER SPRING, Maryland (Reuters) - An experimental obesity drug from Vivus Inc won the backing of a U.S. advisory panel on Wednesday, raising hopes regulators would approve a weight-loss pill for the first time in 13 years.
A panel of outside experts to the Food and Drug Administration voted 20-2 to recommend approval of Qnexa, meant to treat obesity and its accompanying health problems.
The FDA rejected Vivus' Qnexa in 2010 because of safety concerns related to heart rate and birth defects, along with two other obesity pills that are also seeking a second round of consideration.
An advisory committee in 2010 voted 10-6 that safety concerns overwhelmed the benefits of Qnexa.
But this time most panelists were convinced that Qnexa's benefits to treat obesity outweighed its risks, but adding that there should be a post-approval study on heart risks.
Panelist also supported the company's plans to carefully control who gets the drug and limit it to women who are not pregnant. These plans were not part of Vivus's first submission.
"I think everyone around the room knows obesity and its substantial health risks," said Dr. Susan Yanovski, panel member and director of the obesity and eating disorders program at the National Institutes of Health.
"I would say not treating obesity is not risk neutral. We have few treatments for obesity for those who don't respond to lifestyle treatments."
The FDA usually follows panel recommendations, although it is not required to. It will make a final decision by April 17.
Qnexa, which combines the appetite suppressant phentermine and anti-seizure drug topiramate, helped patients lose at least 10 percent of their weight after a year of treatment, the company said.
Obesity, a leading cause of diabetes, heart disease and other serious health problems, has reached epidemic proportions in the United States, with about a third of the population obese and more than half overweight.
The FDA has set a high approval bar for weight loss drugs because such a large portion of the general population is likely to want to take them, and has not approved a new obesity drug since 1999.
Shares of Vivus were halted on Nasdaq on Wednesday pending the outcome of the FDA panel meeting. They closed at $10.55 on Tuesday, well above the stock's low around $4.70 after the pill was first rejected.
(Reporting by Anna Yukhananov; Editing by Tim Dobbyn)
U.S. advisers back experimental obesity pill
SILVER SPRING, Maryland (Reuters) - An experimental obesity drug from Vivus Inc won the backing of a U.S. advisory panel on Wednesday, raising hopes regulators would approve a weight-loss pill for the first time in 13 years.
A panel of outside experts to the Food and Drug Administration voted 20-2 to recommend approval of Qnexa, meant to treat obesity and its accompanying health problems.
The FDA rejected Vivus' Qnexa in 2010 because of safety concerns related to heart rate and birth defects, along with two other obesity pills that are also seeking a second round of consideration.
An advisory committee in 2010 voted 10-6 that safety concerns overwhelmed the benefits of Qnexa.
But this time most panelists were convinced that Qnexa's benefits to treat obesity outweighed its risks, but adding that there should be a post-approval study on heart risks.
Panelist also supported the company's plans to carefully control who gets the drug and limit it to women who are not pregnant. These plans were not part of Vivus's first submission.
"I think everyone around the room knows obesity and its substantial health risks," said Dr. Susan Yanovski, panel member and director of the obesity and eating disorders program at the National Institutes of Health.
"I would say not treating obesity is not risk neutral. We have few treatments for obesity for those who don't respond to lifestyle treatments."
The FDA usually follows panel recommendations, although it is not required to. It will make a final decision by April 17.
Qnexa, which combines the appetite suppressant phentermine and anti-seizure drug topiramate, helped patients lose at least 10 percent of their weight after a year of treatment, the company said.
Obesity, a leading cause of diabetes, heart disease and other serious health problems, has reached epidemic proportions in the United States, with about a third of the population obese and more than half overweight.
The FDA has set a high approval bar for weight loss drugs because such a large portion of the general population is likely to want to take them, and has not approved a new obesity drug since 1999.
Shares of Vivus were halted on Nasdaq on Wednesday pending the outcome of the FDA panel meeting. They closed at $10.55 on Tuesday, well above the stock's low around $4.70 after the pill was first rejected.
(Reporting by Anna Yukhananov; Editing by Tim Dobbyn)
US health experts give nod to new obesity drug
A new drug to treat advanced skin cancer, or metastatic melanoma, has been shown to nearly double average survival time in a study of more than 130 patients, researchers said Wednesday.
FDA panel backs previously rejected obesity pill
SILVER SPRING, Md. (AP) — A previously rejected weight loss pill won an overwhelming endorsement from public health advisers Wednesday, raising hopes that the drug from Vivus Inc. could become the first new anti-obesity medication to reach the U.S. market in more than a decade.
The Food and Drug Administration has rejected three weight loss pills in the last two years, including Vivus' pill Qnexa, due to safety concerns. Experts agree new weight loss drugs are needed to treat an estimated 75 million obese adults in the U.S., but the string of rejections has raised questions of whether any pharmaceutical treatment is safe enough to win approval.
At a public meeting Wednesday, an FDA panel of outside physicians voted 20-2 in favor of the weight loss drug from Vivus, setting the stage for a potential comeback for a drug that has been plagued by safety questions since it was first submitted to the agency in 2010.
Nearly all the panelists backed the drug due to its impressive weight loss results, with most patients losing nearly 10 percent of their overall weight after a year on the drug. But the group stressed that the drugmaker must be required to conduct a large, follow-up study of the pill's effects on the heart. Studies of Qnexa show it raises heart rate and causes heart palpitations, a longtime concern with diet pills over the years. The group of experts said it is still unclear if those side effects lead to heart attack and more serious cardiovascular problems.
"The potential benefits of this medication seem to trump the side effects, but in truth, only time will tell," said Dr. Kenneth Burman of the Washington Hospital Center.
The FDA is not required to follow the advice of its panels, though it often does. A final decision on the drug is expected by mid-April.
In a key question, the physicians said Vivus could conduct the cardiovascular safety study after FDA approval. A requirement to conduct the study ahead of market approval would cost the company millions of dollars and take at least three more years.
"There is an urgent need for better pharmacologic options for individual patients with obesity," said Dr. Elaine Morrato, of the University of Colorado. "I believe Qnexa demonstrated a meaningful efficacy benefit and that there are consequences to not treating obesity."
Vivus, based in Mountain View, Calif., is one of three small drugmakers racing to bring the first new prescription weight loss drug to market in more than a decade. In the past two years the Food and Drug Administration has rejected pills from all three: Arena Pharmaceuticals Inc., Orexigen Therapeutics Inc. and Vivus. All three companies are in the process of resubmitting their products.
The FDA rejected Qnexa in October 2010, citing numerous side effects including elevated heart rate, psychiatric problems and birth defects. Vivus has resubmitted the drug with additional follow-up information on safety, hoping for a more favorable ruling.
Vivus President Peter Tam said the overwhelming panel vote Wednesday indicates doctors recognize the urgent need for effective weight loss drugs.
"Right now there aren't any good treatments out there besides dieting and bariatric surgery — clearly there's a huge gap," Tam said.
With U.S. obesity rates nearing 35 percent among adults, doctors and public health officials say new weight-loss therapies are desperately needed. And even a modestly effective drug could have blockbuster potential. Analysts expect a new weight loss pill to garner at least 10 million users within a few years.
Qnexa is a combination of two older drugs: the amphetamine phentermine, which is approved for short-term weight loss, and topiramate, an anti-seizure and anti-migraine drug sold by Johnson & Johnson as Topamax. Phentermine helps suppress appetite, while topiramate is supposed to make patients feel more satiated.
Along with heart safety, panelists raised concerns about potential birth defects in women who become pregnant while taking Qnexa: topiramate is known to more than double the risk of birth defects.
There were 34 pregnancies among 3,386 women enrolled in Vivus' studies of Qnexa, despite precautions to make sure women used contraception. An FDA expert on birth defects estimated there would be five babies born with a cleft lip defect for every 1,000 women who became pregnant while taking Qnexa.
If approved, FDA scientists said they would require Vivus to train prescribers to educate patients on the pregnancy risks of Qnexa. The drug would only be available from 10 mail-order pharmacies.
Qnexa's other ingredient, phentermine, was one half of the dangerous fen-phen combination, a weight loss treatment pushed by doctors that was never approved by the FDA. The regimen was linked to heart-valve damage and lung problems in the late 1990s, and the FDA forced drugmaker Wyeth to withdraw two versions of its drug fenfluramine.
Fen-phen is just one example in the decadeslong history of failed weight loss drugs, which have continued to pile up in recent years.
Four years ago Sanofi-Aventis SA discontinued studies of its highly anticipated pill Acomplia due to psychiatric side effects, including depression and suicidal thoughts. In 2010, Abbott Laboratories withdrew its drug Meridia after a study showed it increased heart attack and stroke. The drug won approval in 1997 in the wake of the recall of fenfluramine but never achieved widespread use due to modest weight loss and safety concerns. Only 100,000 prescriptions were written in the U.S. during Meridia's last full-year on the market.
Currently there is just one prescription drug on the market for long-term weight loss: Roche's Xenical, which is sold over the counter as alli by GlaxoSmithKline. The drug is not widely used because of modest weight loss results and unpleasant side effects, including gas and diarrhea.
Chủ Nhật, 19 tháng 2, 2012
Vivus obesity drug has safety risks: FDA staff
(Reuters) - Vivus Inc's obesity drug Qnexa helped people lose weight but may cause long-term health problems in overweight and obese patients, U.S. drugs reviewers said.
Food and Drug Administration staff will ask an advisory panel to consider whether the drug's benefits for obese patients will outweigh its risk of birth defects and heart problems.
The FDA staff, in documents posted online on Friday, said patients taking Qnexa during a clinical trial lost more weight, and kept it off for longer, than patients taking a placebo, or sugar pill. These patients also had lower levels of problems associated with obesity, such as issues with blood pressure and blood sugar.
However, the FDA staff said patients taking the drug had more safety problems than patients on a placebo, including memory loss, and these problems could get worse over time. They also said exposure to one of the ingredients in Qnexa has been linked to a higher rate of birth defects in other studies.
Shares of Vivus rose 2.4 percent to $11.45 in pre-market trading.
An advisory panel of outside experts will vote February 22 on whether to recommend the drug, and the FDA is due to make its final decision by April 17.
Qnexa is a combination of appetite suppressant phentermine and anti-seizure drug topiramate.
A company study in December showed topiramate caused a higher rate of oral clefts in infants of women taking the drug during pregnancy, and the company said it would limit Qnexa to women who are not pregnant.
The FDA already rejected Qnexa in 2010 because of safety concerns -- including elevated heart rate in some users and the potential for birth defects if pregnant women used the drug.
Vivus resubmitted its application in October, proposing to limit the drug to only women who cannot have children. In January, the company broadened the label to just limit pregnant women from taking the drug, in response to an FDA request.
(Reporting by Anna Yukhananov; Editing by Derek Caney and Steve Orlofsky)
Gene Might Boost Risk for Obesity
SUNDAY, Feb. 19 (HealthDay News) -- A new animal study suggests that a genetic mutation could put certain people at higher risk for becoming obese if they eat high-fat diets.
At the moment, the practical uses of the research seem to be limited, but physicians could conceivably test people for the mutation and recommend that they avoid certain kinds of diets, said study co-author Dr. Gozoh Tsujimoto, a professor at Kyoto University's department of genomic drug discovery science in Japan. It may also be possible, Tsujimoto said, to eventually give people drugs to combat the effects of the mutation.
If that happens, there would be "a new avenue for personalized health care," Tsujimoto said.
Scientists have been busy studying genetic links to obesity that could make some people more prone to gain extra weight. Two-thirds of Americans are either overweight or obese, the U.S. Centers for Disease Control and Prevention estimates. Excess pounds contribute to a variety of diseases, including heart disease and cancer.
In the new study, researchers looked at the component of the body's internal communication system that plays a role in the regulation of appetite and the production of fat cells.
The investigators found that mice that didn't have the component were 10 percent fatter than other mice when all were fed a high-fat diet. Mice without the component also developed higher intolerance to glucose.
Research conducted in animals does not always translate into humans, and much more research is needed. However, the researchers found that Europeans with the genetic mutation, known as GPR120, were more likely to be obese.
"Our study for the first time demonstrated the gene responsible for diet-induced obesity," Tsujimoto said.
According to Tsujimoto, more than 3 percent of Europeans have the trait. The next step for researchers is to study its prevalence in Japanese, Korean and Chinese people.
What can be done with the knowledge from the study?
Tsujimoto said physicians could advise people with the trait to avoid high-fat diets. A test is available to detect the trait and it costs about $200 in Japan, Tsujimoto said.
While medications could potentially be developed that would reverse the effects of the genetic trait, there are no such drugs now, Tsujimoto added.
Ruth Loos, director of Genetics of Obesity and Related Metabolic Traits at Mount Sinai School of Medicine in New York City, said "these findings provide another piece of what turns out to be the very large puzzle that describes the causes of obesity."
Consistent findings in mice and humans have put the trait "more firmly on the obesity map and provides a new starting point for more research into the function of this gene," said Loos.
"This is only the beginning of likely many years of research to disentangle the physiological mechanisms that lie behind the link between this gene and obesity risk," she said. "It is only when we understand the physiology and biology better that one can start thinking of developing a drug."
The study appears online Feb. 19 in the journal Nature.
More information
For more on obesity, visit the U.S. National Library of Medicine.
Modest hope for FDA approval of Vivus obesity drug
(Reuters) - Hopes were raised slightly on Friday that U.S. health regulators could approve a weight-loss pill for the first time in 13 years, after government reviewers did not flag fresh safety risks for an experimental obesity drug from Vivus Inc.
Food and Drug Administration staff said in documents posted online that the drug Qnexa did help people lose weight, though they reiterated concerns about the risk of birth defects and heart problems.
The FDA rejected Qnexa in 2010 because of safety problems, and on Friday agency staff still seemed skeptical about the drug's long-term health effects, especially on the heart.
FDA staff will ask a panel of outside experts next Wednesday to consider whether the benefits of Qnexa for obese patients outweigh its safety risks, or if the company needs to do more studies.
Obesity, a leading cause of diabetes, heart disease and other serious health problems, has reached epidemic proportions in the United States, with about a third of the population affected.
But the FDA has set a high approval bar for weight loss drugs because such a large portion of the general population is likely to want to take them. The agency has not approved a new obesity drug since 1999.
Qnexa is one of three obesity pills up for a second round of consideration from the FDA.
"Ultimately, only a long-term, cardiovascular outcome trial can define the effect of (Qnexa) treatment on risk for major adverse cardiovascular events in an obese at-risk population," FDA reviewers said about Qnexa.
The FDA staff said they would also ask the advisers whether Vivus needs to do a heart-focused study of Qnexa before it is approved. The FDA will make its final decision by April 17.
FDA staff said patients taking Qnexa during a clinical trial had lost more weight, and kept it off for longer, than those taking a placebo, or sugar pill. The Qnexa patients also had lower levels of problems associated with obesity, such as issues with blood pressure and blood sugar.
However, the FDA staff said patients taking the drug had more safety problems, including memory loss and higher heart rates, than those on a placebo, and some of these problems could get worse over time.
They also said exposure to one of the ingredients in Qnexa has been linked to a higher rate of birth defects in other studies.
REAL-WORLD PROBLEMS
Qnexa is a combination of appetite suppressant phentermine and anti-seizure drug topiramate.
A company study showed topiramate caused a higher rate of oral clefts in infants of women taking the drug during pregnancy, and the company said it would limit Qnexa to women who are not pregnant.
Vivus resubmitted its application to the FDA in October with more data and proposed to limit the drug to only women who cannot have children. In January, the company broadened the label to just limit pregnant women from taking it, in response to an FDA request.
Jason Butler, an analyst at JMP Securities, said the FDA's request to allow non-pregnant women to take the drug was a positive sign.
"The FDA is saying ... it's a small signal of risk, but it's not so great that we have to stop people using it," Butler said, adding he expected heart issues to be a greater concern.
However, in its review on Friday, the FDA staff said limiting the drug to nonpregnant women might be difficult in the real world, especially since 34 women got pregnant during the clinical trial.
Vivus is not the only company vying to get an obesity drug on the market.
Arena Pharmaceuticals and Orexigen Therapeutics have been pitching their own fat-fighters again to the FDA after rejections.
In February, Orexigen agreed with the FDA on the design of a 10,000-patient heart-safety trial required for the approval of its Contrave drug.
The FDA is also set to review Arena's lorcaserin by June 27, after rejecting it in October 2010 because of a potential cancer risk.
Drugmakers have struggled for years to develop weight-loss drugs that are both effective and safe.
Back in 1997, the infamous diet drug "fen-phen" was pulled from the market after reports of fatal heart-valve problems in some users. Another diet pill, Meridia, was pulled from the U.S. market in 2010 after being linked to heart problems.
The only prescription obesity drug currently approved for long-term use is Roche Holding AG's Xenical, which got the FDA's nod in 1999. GlaxoSmithKline markets a lower-dose, over-the-counter version called Alli. But both have their own problems, as they can cause serious liver problems, uncontrolled bowel movements and gas.
Thứ Ba, 7 tháng 2, 2012
Orexigen, FDA agree on trial design for obesity drug
US cooking star Paula Deen, self-proclaimed "Queen of Southern Cuisine" famous for her dishes smothered in butter, has met a storm of outrage after revealing she has diabetes and is hawking a drug to treat the disease.
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